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GSK to present bepirovirsen in chronic hepatitis B at International Liver Congress 2022

June 15, 2022: “GSK plc will present 12 abstracts at the European Association for the Study of the Liver’s International Liver Congress 2022, taking place on June 22-26 in London.

GSK’s presence will focus on two novel investigational specialty medicines, bepirovirsen, an antisense oligonucleotide for chronic hepatitis B (CHB), and linerixibat, an ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus in primary biliary cholangitis (PBC).

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Chris Corsico, SVP, Development, GSK said: “New data being shared at this year’s International Liver Congress support our ambition to deliver novel medicines for patients with significant unmet medical need, such as those who suffer from chronic hepatitis B and cholestatic pruritus in primary biliary cholangitis.

We look forward to engaging with the global hepatology community to share the exciting progress we have made for these patients.”

Updates from the bepirovirsen clinical trial programme

New interim analysis data to be shared from the randomised B-Clear phase IIb trial evaluating the efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection on and off stable nucleos(t)ide analogue therapy.

Data from this trial will be presented as part of the Late Breaker oral presentation session on June 25 (ILC oral # LB004A, LB004B).

Additional presentations from the bepirovirsen development programme include:

  • Preclinical evidence that bepirovirsen harbours intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8), correlating with clinical efficacy from the study (ILC abstract #3635/ SAT439)
  • Mechanistic pharmacokinetic and pharmacodynamic modelling of the simultaneous effects of bepirovirsen on hepatitis B surface antigen (HBsAg) and alanine transaminase (ALT) changes in CHB (ILC abstract #3592/ SAT441).

Data from these trials reflect GSK’s ambition to contribute to the development of a functional cure for people living with CHB and reduce the disease burden for patients.

Updates from the linerixibat clinical trial programme

New analysis to be presented from the GLIMMER phase II trial comparing the health-related quality of life of patients with cholestatic pruritus in PBC to several more common diseases, using EQ-5D, a standardised measure of health utility.

The data from this analysis demonstrate that severe cholestatic pruritus in PBC has a negative impact on health utility that is similar to severe Parkinson’s disease (ILC abstract #1916/ THU470).

Full list of GSK’s presentations at the European Association for the Study of the Liver’s International Liver Congress 2022:

Bepirovirsen

Abstract NamePresenterPresentation details
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection: interim results from the randomised phase 2b B-Clear study Man-Fung Yuen Oral (LB004A, LB004B)
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection not on stable nucleos(t)ide analogue therapy: interim results from the randomised phase 2b B-Clear study Seng-Gee LimPoster (3595/ SAT452)
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection on stable nucleos(t)ide analogue therapy: interim results from the randomised phase 2b B-Clear study Man-Fung Yuen Poster (3629/ SAT453)
Evaluation Of Quantitative HBsAg Levels In Chronic Hepatitis B – A Targeted Literature Review Vera Gielen Poster (1850/ SAT405)
Characterisation of baseline complement values in patients with chronic hepatitis B virus infection in the phase IIb B-Clear study Jennifer Cremer  Poster (1994/ THU390)
Characteristics and renal function in patients with chronic hepatitis B virus infection: baseline data from the phase 2b B-Clear study Seng-Gee Lim Poster (1879/ THU389)
Distribution of patients by guideline-defined disease phase and/or grey zones in B-Clear, an international multi-centre clinical trial Seng-Gee Lim  Poster (2127/ THU393)
Bepirovirsen, antisense oligonucleotide (ASO) against hepatitis B virus (HBV), harbors intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8) preclinically, correlating with clinical efficacy from the Phase 2a study Shihyun You Poster (3635/ SAT439)
Mechanistic Pharmacokinetics/Pharmacodynamics modelling of the simultaneous effects of bepirovirsen on Hepatitis B surface antigen (HBsAg) and alanine transaminase (ALT) changes in Chronic Hepatitis B (CHB) patients: Analysis of Phase 2b study to inform Phase 3 decision-making Ahmed Nader Poster (3592/ SAT441)
Combination treatment of a PAPD5/7 inhibitor with an antisense oligonucleotide bepirovirsen with concurrent dosing shows additive HBsAg decreases in the AAV-HBV mouse modelMartin LeiversPoster (3590/ SAT451)

Linerixibat

Abstract NamePresenterPresentation details
More than just an itch: Impact of cholestatic pruritus in primary biliary cholangitis (PBC) on health-related quality of life (HRQoL) Helen Smith Poster (1916/ THU470)
Linerixibat dose-response analysis of C4 concentrations as a quantitative approach to predict gastrointestinal tolerability Fernando CarreñoPoster (2056/ THU472)
Investigation of linerixibat 40mg BID for cholestatic pruritus of primary biliary cholangitis (PBC); further data from the Phase 2b GLIMMER study to support the Phase 3 GLISTEN study James Fettiplace Poster (3606/ THU485)

About chronic hepatitis B

Hepatitis B is a viral infection of the liver, caused by the hepatitis B virus (HBV), it can cause both acute and chronic liver disease.

Chronic hepatitis B (CHB) is a long-lasting infection and occurs when the body’s immune system is unable to fight off the virus and it persists in the blood and liver.

It is estimated that there are 296 million people globally living with CHB.1 Even when treated, CHB can progress to liver complications including cirrhosis and liver cancer, which results in nearly 900,000 deaths per year.

Viral suppression is the current goal for treatment of CHB. However, viral replicative activity may return upon cessation of treatment requiring lifelong therapy to prevent viral rebound.

The concept of functional cure of CHB aims to eliminate the virus from circulating in the blood and prevent any disease activity in the liver.

As only a limited number of patients currently treated for CHB achieve HBsAg loss, considered the hallmark for achieving functional cure, development of therapeutic approaches to reach functional cure are needed.”

https://www.gsk.com/en-gb/media/press-releases/gsk-to-present-new-data-from-the-b-clear-phase-iib-trial-for-bepirovirsen-in-chronic-hepatitis-b-at-the-international-liver-congress-2022/

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